Senior Clinical Scientist

Working within a matrixed environment, the Senior Clinical Scientist will be a cross- functional influencer in the maturation of the global product development plan, including the clinical development plan, clinical trial design, study protocol, and clinical study execution. Work with the Therapeutic Area Head as well as Medical Director(s), to create key strategic documents, including the clinical development plan, protocol concept and full protocol for one or more products in early-stage development, while also contributing to product(s) in later stages of development, including NDA filings Contribute to the key documents describing products in development, such as the Investigators' Brochure and safety updates Contribute to correspondence with the health authorities approached by the assigned programs, such as the briefing book, IND, NDA, as well as responses to health authority questions Develop a working knowledge of the operational characteristics of the clinical endpoints relevant to the assigned clinical trial indication, the study population represented by various inclusion/exclusion criteria or diagnoses, and their use in previous clinical trials, to enable informed and innovative clinical trial design Develop a working knowledge of the clinical scales and patient reported outcome tools associated with the assigned clinical trial indication to facilitate their qualification and justification for regulatory correspondence and study start up activities Develop a working knowledge of the biomarkers and other measured endpoints associated with the assigned clinical programs, their assay characteristics, sample handling requirements, and qualification needs, if any Ensure that all studies observe the highest standards of ethical and safe conduct, and ensure compliance with GCP; monitor study progress and perform medical data review for endpoint and safety management to ensure integrity of study data Develop effective working relationships with investigators in assigned programs Analyze and interpret study data from an individual study; translate study level clinical data across the program of studies for a particular drug Facilitate the awareness of the real-time availability of clinical trial data (including safety, efficacy, pharmacokinetic and biomarker data), to provide consolidated information for dose escalation meetings, data safety monitoring boards, and interim analyses Assist Clinical Operations in developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties Minimum of a college degree in life sciences or nursing degree, advanced degree preferred (i.e. MD, PhD, PharmD or MS) Minimum of 5 years of experience in clinical research or equivalent Clinical trial/drug development Phase 1-3 expertise highly desirable The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize.